tag:blogger.com,1999:blog-57543419328338816742026-01-15T10:36:16.618+00:00Computer Systems Validation and Quality Assurance blogAnonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.comBlogger46125tag:blogger.com,1999:blog-5754341932833881674.post-6034499146157780562012-11-05T19:00:00.000+00:002012-11-06T11:40:40.066+00:00

In the article Validation Determination the use of categorising software was discussed and how this can support the approach to the validation. In this post we are looking at types of software which fall in to these categories for Process Control Systems / Automation Systems. Categorising software is used to support the approach to the validation based on complexity and novelty of the

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-56555868018429706972012-08-29T16:59:00.000+01:002012-08-29T17:03:45.883+01:00

In the article Computer System Impact / Risk Assessment from May 2010 I discussed the use of the Impact Assessment for a Computerised system to determine the validation requirements. This article continues with that theme to provide guidance on performing and documenting the assessment within a Validation Determination Statement (VDS) for a computerised system. GxP AssessmentThe first stage of

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-50489898393168706422012-07-30T12:58:00.002+01:002012-07-30T12:58:33.682+01:00

Date: 13 June 2012 Link FDA 483 (New Window) Observation 5. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed in the release of drug products [21 C.F.R. 211.68 (a)] For example, your firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-23242334700429494232012-04-10T18:00:00.000+01:002013-02-27T13:22:44.662+00:00

Date: 23 February 2012 Link FDA 483 (New Window) Observation4. Your firm has not established appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Your firm also fails to maintain a backup file of data entered into the computer or related system [21 CFR § 211.68(b)]. For

Anonymoushttp://www.blogger.com/profile/17337360803458638384noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-19469103257039529542012-02-22T14:58:00.001+00:002012-02-19T15:42:36.377+00:00

Date: 03 February 2012 Link FDA 483 (New Window) ObservationAlthough this observation does not directly relate to 21CFR211.68 for computerised systems it still has an impact on the validation requirements of an automated system within a tablet manufacturing and packing line. 4. Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-72280586404901241512012-01-09T20:30:00.000+00:002012-05-04T15:49:14.234+01:00

Within EU Chapter 4 – Documentation there is a clear definition of Raw Data and the requirements to retain the raw data. Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which

Anonymoushttp://www.blogger.com/profile/17337360803458638384noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-29325036825038678832011-12-10T10:17:00.000+00:002012-08-27T22:03:58.779+01:00

Date: 25 May 11 Link FDA 483 (PDF - New Window) Observation b. During routine operations, if there is an alarm event (e.g., time out, high and low temperature for washing and siliconizing, instrument line failure, jacket gauge failure and steam header failure) during the wash and depyrogenation process, the [redacted] Stopper Washer captures the alarm condition via a print out and the data is

Anonymoushttp://www.blogger.com/profile/17337360803458638384noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-27894979530805932292011-12-07T18:36:00.000+00:002011-12-07T18:36:00.319+00:00

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory). This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the

Anonymoushttp://www.blogger.com/profile/17337360803458638384noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-8494516873704567072011-09-14T18:09:00.000+01:002011-09-14T18:09:00.230+01:00

Date: 25 Aug 11 Link: FDA Warning Letter (New Window) ObservationThis observation relates to the revalidation following changes of a Cutting and Packing Machine, however it could be applied to any computerised system. 2. Your firm failed to ensure that the automatic, mechanical, or electronic equipment, or other types of equipment including computers or related systems, will perform a function

Anonymoushttp://www.blogger.com/profile/17337360803458638384noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-43221312672689157552011-05-18T18:35:00.030+01:002011-05-18T18:35:00.590+01:00

ObservationDate: 25 April 11 Link FDA Warning Letter (New Window) 4. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R 211.68(b)]. For example, your firm lacks control of the (b)(4) computer system which monitors

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-60227338542416755362011-04-18T20:47:00.001+01:002011-04-18T20:47:00.207+01:00

Introduction As discussed in previous posts the regulatory expectation is that risk management will be applied to all lifecycle phases of a computerised system. The recent issue of EU Annex 11 includes risk management at all stages of the computer system lifecycle. GAMP 4 first introduced the concept of risk management and risk assessments and following the issue of the ASTM E52500 Specification

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-27119507916463641692011-04-13T19:13:00.023+01:002011-04-13T19:13:00.295+01:00

IntroductionAlthough to date I have not found any references within the FDA warning letters directly relating to computerised systems and risk assessments within the pharmaceutical / biotechnology industry it is interesting to review inspection findings where risk assessments have been detailed. In this post there is a review of two FDA warning letters which reference the use of documented risk

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-72296760943994246682011-04-11T16:06:00.021+01:002011-04-11T16:06:00.467+01:00

It is a regulatory requirement that access to computerised systems is limited to authorised users. This not only limited to systems that contain electronic records but all systems that are used to fulfil regulated activities. This post focuses on the FDA and MHRA / EU requirements regulatory requirements for security management of computerised systems within the pharmaceutical and biotech

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-975163722962492452011-03-28T19:54:00.003+01:002011-03-31T12:49:30.402+01:00

Electronic Signatures This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that was issued in January 2011 to become effective on the 30 June 2011. As stated in the previous article the EU Annex 11 update does not directly reference Electronic Records this is included in the update to EU Chapter 4 (Documentation). The update to EU Annex 11 however does

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com2tag:blogger.com,1999:blog-5754341932833881674.post-12136016652634403582011-03-04T21:07:00.015+00:002012-09-03T14:58:04.793+01:00

Date: 28 Jan 11 Link: FDA Warning Letter (New Window) ObservationIn addition, we remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-32593823676221639562011-03-02T18:12:00.013+00:002011-03-02T18:12:00.381+00:00

Date: 20 April 2010 Link: FDA Warning Letter (New Window) ObservationThis is a follow up letter from an inspection in 2009 where the security of laboratory systems had been raised within the FDA 483. 6. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-91269910682339824722011-02-28T18:10:00.005+00:002011-03-28T13:15:01.676+01:00

This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that issued in January 2011 to become effective on the 30 June 2011. Electronic Records have for so long only taken guidance from the FDA, however it has always been an expectation of the MHRA / EU that electronic records, including raw data must have the same integrity as paper records. EU Annex 11

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-91476057973623590142011-02-24T16:02:00.003+00:002011-03-28T13:17:17.695+01:00

This is a continuation of a review of the impact of the update to EU Annex 11, issued in January 2011 to become effective on the 30 June 2011. Supplier AuditsThe supplier audit process for software suppliers including IT systems, automation systems, etc has been around for quite some time within the guidance documents, but never directly referenced within cGMPs for pharmaceutical companies (e.g.

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-74979860167962696482011-02-23T18:02:00.004+00:002011-03-28T13:17:37.798+01:00

As stated in the earlier post EU Annex 11 has been updated and becomes effective on the 30 June 2011. This is part of a series of reviews detailing what has changed and the impact on Computer Systems Validation. Risk Management now underpins the whole process of Computer Systems Validation. This has been a driving force since the introduction of GAMP4 and even more so through GAMP5. In the

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-6826186344438588892011-02-11T17:00:00.010+00:002012-04-10T14:14:08.087+01:00

In January 2011 the European Commission (EudraLex) released Annex 11 Computerised Systems (revision 1) which comes in to effect on 30 June 2011. This has been a long awaited release of the GMP Guideline for Computerised Systems which was first issued for comment in April 2008 for public consultation. The final release of Annex 11 has been reduced considerably to that put out for public

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-26752513381461932152010-12-06T19:46:00.023+00:002012-09-03T15:29:35.989+01:00

Hybrid Systems (Deleting Electronic Data) In Hybrid systems the computerised system is used to generate a record which is printed and hand signatures applied. The decision for the regulated company is whether the electronic record (or raw data) should be kept or deleted from the system. In the FDA Guidance “Part 11, Electronic Records; Electronic Signatures — Scope and Application” under

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-44211496884894447812010-12-01T20:11:00.028+00:002010-12-01T20:11:00.637+00:00

Regulatory requirement Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history. FDA 21 CFR 211.68(b) States: “Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com2tag:blogger.com,1999:blog-5754341932833881674.post-54661466208650225272010-08-19T20:08:00.000+01:002010-08-19T20:08:00.311+01:00

Spreadsheets have become commonly used within a wide range of applications within the pharmaceutical and biotechnology industries. These range from the management of documentation lists through to complex algorithms used to support batch release. This post provides a description of a risk based approach to the validation of spreadsheets. As with all posts comments are welcome. The approach to

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-69054488313108823492010-07-21T19:23:00.004+01:002010-08-10T18:11:05.843+01:00

Image via WikipediaAs detailed within the post 21 CFR Part 11 Warning Letters the FDA are planning to start conducting part 11 inspections soon. Published on the FDA website the agency states: The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0tag:blogger.com,1999:blog-5754341932833881674.post-49824086022330555222010-07-10T19:11:00.000+01:002010-07-10T19:11:00.147+01:00

The validation of computer software within the Pharmaceutical Industry is providing documented evidence that the software and computer system is fit for its intended purpose. Quality can not be tested in to the system it must be designed. This is why developing a lifecycle approach to software validation should be taken, to design in quality from concept, through the requirements, design and

Anonymoushttp://www.blogger.com/profile/08530532023864261704noreply@blogger.com0